Clip applier and methods of use

ABSTRACT

A method for delivering a closure element to an opening formed in a wall of a body lumen. The method includes inserting a distal end region of an apparatus into the opening in the wall of the body lumen, moving a third grasping portion toward the first grasping portion to limit movement of the distal end of the apparatus relative to the opening in the wall of the body lumen, and moving a second grasping portion toward the first grasping portion to advance the closure element distally. The second grasping portion and third grasping portion are movable toward the first grasping portion.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a continuation of U.S. patent application Ser. No. 13/898,202,filed May 20, 2013, and entitled CLIP APPLIER AND METHODS OF USE, whichis a continuation of U.S. patent application Ser. No. 13/615,547, filedSep. 13, 2012, and entitled CLIP APPLIER AND METHODS OF USE, now U.S.Pat. No. 8,518,057, which is a continuation of U.S. patent applicationSer. No. 11/427,297, filed Jun. 28, 2006, and entitled CLIP APPLIER ANDMETHODS OF USE, now U.S. Pat. No. 8,313,497, which claims priority toand the benefit of U.S. Provisional Patent Application Ser. No.60/696,069, filed Jul. 1, 2005, and entitled CLIP APPLIER AND METHODS OFUSE, each of which is incorporated herein by reference in its entirety.This application also incorporates by reference U.S. patent applicationSer. No. 10/356,214 and U.S. patent application Ser. No. 10/638,115 intheir entireties.

FIELD OF THE INVENTION

The present invention relates generally to apparatus and methods forclosing and/or sealing openings through tissue, and more particularly toapparatus and methods for delivering a closure element for closing apuncture in a blood vessel or other body lumen formed during adiagnostic or therapeutic procedure.

BACKGROUND OF THE INVENTION

Catheterization and interventional procedures, such as angioplasty orstenting, generally are performed by inserting a hollow needle through apatient's skin and tissue into the vascular system. A guide wire may beadvanced through the needle and into the patients blood vessel accessedby the needle. The needle is then removed, enabling an introducer sheathto be advanced over the guide wire into the vessel, e.g., in conjunctionwith or subsequent to a dilator.

A catheter or other device may then be advanced through a lumen of theintroducer sheath and over the guide wire into a position for performinga medical procedure. Thus, the introducer sheath may facilitateintroducing various devices into the vessel, while minimizing trauma tothe vessel wall and/or minimizing blood loss during a procedure.

Upon completing the procedure, the devices and introducer sheath wouldbe removed, leaving a puncture site in the vessel wall. Traditionally,external pressure would be applied to the puncture site until clottingand wound sealing occur, however, the patient must remain bedridden fora substantial period of time after clotting to ensure closure of thewound. This procedure, however, may be time consuming and expensive,requiring as much as an hour of a physicians or nurses time. It is alsouncomfortable for the patient, and requires that the patient remainimmobilized in the operating room, catheter lab, or holding area. Inaddition, a risk of hematoma exists from bleeding before hemostasisoccurs.

Various apparatus have been suggested for percutaneously sealing avascular puncture by occluding the puncture site. For example, U.S. Pat.Nos. 5,192,302 and 5,222,974, issued to Kensey et al., describe the useof a biodegradable plug that may be delivered through an introducersheath into a puncture site. Another technique has been suggested thatinvolves percutaneously suturing the puncture site, such as thatdisclosed in U.S. Pat. No. 5,304,184, issued to Hathaway et al.

To facilitate positioning devices that are percutaneously inserted intoa blood vessel, “bleed back” indicators have been suggested. Forexample, U.S. Pat. No. 5,676,974, issued to Kensey et al., discloses ableed back lumen intended to facilitate positioning of a biodegradableplug within a puncture site. This device, however, requires that ananchor of the plug be positioned within the vessel, and therefore, mayincrease the risk of over-advancement of the plug itself into thevessel.

Alternatively, U.S. Pat. No. 5,674,231, issued to Green et al.,discloses a deployable loop that may be advanced through a sheath into avessel. The loop is intended to resiliently expand to engage the innerwall of the vessel, thereby facilitating holding the sheath in a desiredlocation with respect to the vessel.

Accordingly, apparatus and methods for delivering a device for closing avascular puncture site or other opening through tissue would be useful.

BRIEF SUMMARY

The present invention is directed toward an apparatus and method fordelivering a closure element through tissue and into an opening formedin, or adjacent to, a wall of a blood vessel or other body lumen of anysize. The apparatus can be configured to receive and retain the closureelement so that the closure element can be disposed substantially withinthe apparatus. Thereby, when the apparatus is introduced via anintroducer sheath, for example, the closure element can be disposedwithin and delivered by way of a lumen of the introducer sheath. Theapparatus can also be configured to engage the blood vessel walladjacent to the opening and to position the closure elementsubstantially adjacent to an outer surface of the blood vessel walladjacent to the opening.

When properly positioned, the apparatus can be activated to distallydeploy the closure element. During deployment, the apparatus can beconfigured to substantially uniformly expand the closure element beyonda natural cross-section of the closure element such that the closureelement, when deployed, can be configured to engage the blood vesselwall and/or tissue. Engaging the blood vessel wall and/or tissue, theclosure element can be further configured to return to the naturalcross-section. Thereby, the engaged blood vessel wall and/or tissue aredrawn substantially closed and/or sealed, such that, for example,hemostasis within the opening can be enhanced.

The present invention can also accommodate for variations in the size ofthe physicians hand and grip by selectively reducing the distancebetween the devices handle portion and a portion of a triggering systemusable to deploy the closure element. The triggering system of theapparatus can at least partially move a trigger extension graspable by aphysician or clinician as a locator assembly locates the blood vesselwall prior to deploying the closure element. This partial movementreduces the gap between the trigger extension and the handle portion. Inthis manner, a physician or clinician does not need to stretchuncomfortably to position a thumb or finger on the trigger extension,grasping the handle portion, and maintaining the device in the desiredorientation relative to the tissue and/or the puncture site.

An apparatus of the present invention is usable to deliver a closureelement to an opening formed in a wall of a body lumen. The apparatuscan include a locator assembly having a distal end region configured toextend into the opening and selectably contact the wall of the bodylumen and a proximal end configured to cooperate with a movable plunger.A carrier assembly can be coupled with the locating assembly, thecarrier assembly retaining the closure element in a substantiallytubular configuration within the carrier assembly. A triggering systemcan also cooperate with the locator assembly, the triggering system canmove toward the distal end region of the locator assembly as the movableplunger moves toward the distal end region. In one configuration, thetriggering system can move toward the distal end region substantiallysimultaneously with the distal end region transitioning from theunexpanded state to the expanded state.

The locator assembly of the apparatus can further include a locatorcontrol system coupled to a proximal end region of the locator assembly.This locator control system can be configured to selectively control thedistal end region of the locator assembly between the expanded state andthe unexpanded state. In one configuration, the locator control systemcan include a tubular body block mounted to a tubular member, a springretainer receiving a portion of the tubular body block, and a movableplunger slidably cooperating with the tubular body block and the tubularmember.

The present invention can also provide a stable base upon which thephysician or clinician can move the device or apparatus as the closureelement is positioned and deployed. In one configuration, the stablebase is formed from the handle portion having two graspable portions: ashaped grasping portion and an elongated grasping portion. The shapedgrasping portion can be configured to receive at least a thumb or fingerof the physician. A portion of the handle portion can have a curvedprofile to enable a portion of the handle to fit comfortably within auser's hand while the hand is rested on a patient during the procedureto provide stability during use of the device and function as a based orpivot point for moving the remainder of the device or apparatus.

Other aspects and features of the present invention will become apparentfrom consideration of the following description in conjunction with theaccompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to describe the manner in which the above-recited and otheradvantages and features of the invention can be obtained, a moreparticular description of the invention briefly described above will berendered by reference to specific embodiments thereof which areillustrated in the appended drawings. Understanding that these drawingsdepict only typical embodiments of the invention and are not thereforeto be considered to be limiting of its scope, the invention will bedescribed and explained with additional specificity and detail throughthe use of the accompanying drawings.

FIG. 1A illustrates an assembly view of the components of one embodimentaccording to the present invention for closing openings in blood vesselwalls.

FIG. 1B illustrates another assembly view of the components of oneembodiment according to the present invention for closing openings inblood vessel walls.

FIG. 2 illustrates the assembled carrier assembly and triggeringassembly of the apparatus shown in FIGS. 1A and 1B.

FIG. 3A illustrates a close-up view of the proximal end of the apparatusshown in FIG. 2.

FIG. 3B illustrates a close-up view of the distal end of the apparatusshown in FIG. 2 in an unexpanded state.

FIG. 3C illustrates a close-up view of the distal end of the apparatusshown in FIG. 2 in an expanded state.

FIG. 4 illustrates the apparatus of FIG. 2 after distal advancement ofthe locator assembly, the triggering system and the carrier assembly.

FIG. 5 illustrates a close-up view of the triggering system and carrierassembly of the apparatus shown in FIG. 4.

FIG. 6 illustrates the apparatus of FIG. 1A-1B after the clip has beenreleased to close the opening in the tissue.

FIG. 7 illustrates a close-up view of the triggering system and carrierassembly of the apparatus of FIG. 1A-1B after the clip has been releasedto close the opening in the tissue.

FIG. 8 illustrates a cross-sectional schematic view of the distal end ofthe apparatus shown in FIG. 4 as assembled for deployment.

FIG. 9 illustrates a plan view of an alternative embodiment of anapparatus for closing openings in tissue in accordance with the presentinvention.

FIG. 10 illustrates a portion of a housing half of the alternativeembodiment of FIG. 9, illustrating the functional components thereof.

FIG. 11A illustrates a portion of a housing half of the alternativeembodiment of FIG. 9, without certain functional components.

FIG. 11B illustrates a portion of a locator control system of thealternative embodiment of FIG. 9.

FIG. 11C illustrates a portion of a locator release system of thealternative embodiment of FIG. 9.

FIG. 11D illustrates a side view of a plunger of the locator controlsystem of FIG. 11B of the alternative embodiment of FIG. 9.

FIG. 11E illustrates a perspective view of a tubular body block of thelocator control system of FIG. 11B of the alternative embodiment of FIG.9.

FIG. 11F illustrates a perspective view of a spring retainer of thelocator control system of FIG. 11B of the alternative embodiment of FIG.9.

FIG. 12 illustrates a close-up cross-sectional view of the proximal endof the apparatus shown in FIG. 9, illustrating the initial position ofthe locator control system.

FIG. 13 illustrates a close-up cross-sectional view of the proximal endof the apparatus shown in FIG. 9, illustrating the final position beforeclip release of the locator control system.

FIGS. 14A-14G illustrate various embodiments of closure elements thatcan be utilized with the apparatus of the present invention.

FIGS. 15A-K illustrate various steps in the deployment of embodiments ofthe present invention.

It should be noted that the figures are not drawn to scale and thatelements of similar structures or functions are generally represented bylike reference numerals for illustrative purposes throughout thefigures. It also should be noted that the figures are only intended tofacilitate the description of embodiments of the present invention.

DETAILED DESCRIPTION

The embodiments described herein extend to methods, systems, andapparatus for closing and/or sealing openings in a blood vessel or otherbody lumen formed during a diagnostic or therapeutic procedure. Theapparatuses of the present invention are configured to deliver a closureelement through tissue and into an opening formed in and/or adjacent toa wall of a blood vessel or other body lumen.

Since current apparatuses for sealing openings formed in blood vesselwalls can snag tissue adjacent to the openings during positioning andmay not provide an adequate seal, an apparatus that is configured toprevent inadvertent tissue contact during positioning and to engagetissue adjacent to the opening can prove much more desirable and providea basis for a wide range of medical applications, such as diagnosticand/or therapeutic procedures involving blood vessels or other bodylumens of any size. Further, since current apparatuses for sealingopenings formed in blood vessel walls are typically one-size and do notprovide a mechanism to accommodate for variations in the size orconfiguration of the physician or clinicians hands, an apparatus thatvaries its operational configuration to accommodate for physician orclinician hand sizes can prove much more desirable and beneficial to themedical arts. These results, whether individually or collectively, canbe achieved, according to one embodiment of the present invention, byemploying an apparatus as shown in the figures and described in detailbelow.

As will be discussed in more detail below, the apparatuses of thepresent invention are configured to deliver a closure element throughtissue and into an opening formed in and/or adjacent to a wall of ablood vessel or other body lumen. The apparatus can be configured toreceive and retain a closure element such that the closure element canbe disposed substantially within the apparatus. The apparatuses inaccordance with the present invention generally include a handle portionhaving a proximal end and a distal end, a locator and clip deliveryassembly extending from the distal end of the handle portion, and alocator actuator disposed at the proximal end of the handle portion.

Referring now to FIG. 1, an exploded assembly view of one closureapparatus is shown in accordance with the present invention. As shown inFIG. 1, the apparatus can include a housing that receives or retains aplurality of tubular members. The tubular members can be concentricallydisposed within the housing of the device, with each tubular memberhaving an associated block member fixedly attached to the proximal endthereof. The block members can be configured to interact with each otheras well as with features of the housing, such as through movement of atriggering system. The interaction of the tubular members, the blocks,and the triggering system will be described in greater detail below.Also described below will be additional details regarding the handleportion of the housing and the manner by which the movement of thetubular members and the triggering system results in variation of thedevices operational configuration to accommodate for physician orclinician hand sizes.

With continued reference to FIGS. 1A and 1B, apparatus 100 can beprovided as one or more integrated components and/or discrete componentsthat may be retained within a housing 102, having a housing top half 380c and a housing bottom half 380 d (not shown). For example, apparatus100 can include a locator assembly 110 and a carrier assembly 120. Forpurposes of illustration, locator assembly 110 and carrier assembly 120are shown in FIG. 1A as comprising substantially separate assemblies. Asdesired, however, locator assembly 110 and carrier assembly 120 each canbe provided, in whole or in part, as one or more integrated assemblies.

Turning to FIGS. 1A-2, 4, and 6, the assembly 110 can include a locatorassembly 200. This locator assembly 200 can include flexible orsemi-rigid tubular body 210 (such as an elongate rail) with alongitudinal axis. Tubular body 210 can have a proximal end region 210 aand a distal end region 210 b and can include a predetermined length anda predetermined outer cross-section, both of which can be of anysuitable dimension. Distal end region 210 b of locator assembly 200, asshown in more detail in FIGS. 3B and 3C, can include a substantiallyrounded, soft, and/or flexible distal end or tip 220 to facilitateadvancement and/or retraction of distal end region 210 b into a bloodvessel or other opening in tissue. As desired, a pigtail (not shown) maybe provided on tip 220 to further aid atraumatic advancement of distalend region 210 b.

Distal end region 210 b of locator assembly 200 is selectablycontrollable between an unexpanded state, as shown in FIG. 3B, and anexpanded state, as shown in FIG. 3C. As shown in FIG. 3B, when anexpansion end 230 is in an unexpanded state, substantially flexiblemembers 232 are substantially axially aligned with locator assembly 200.Alternatively, when expansion end 230 is in an expanded state,substantially flexible members 232 are flexed outward.

Returning to FIG. 1B, a control member 250, such as a rod, wire, orother elongate member, may be moveably disposed within a lumen (notshown) formed by tubular body 210 and extending substantially betweenthe proximal end region 210 a and distal end region 210 b. Controlmember 250 may have proximal end region 250 a coupled with a controlblock 260, and a distal end region 250 b coupled with distal end region210 b of locator assembly 200, expansion end 230, and/or the movable endregions of substantially flexible members 232. Control block 260 may beformed of a metal or rigid plastic in a tubular shape, and may beadapted to be retained in control block cavity 265 formed on theinternal surface of housing bottom half 380 d, to thereby maintaincontrol block 260 in a substantially fixed position relative to thehousing 380. By moving tubular body 210 axially relative to controlmember 250, the distal end region 210 b, expansion end 230, and/or thesubstantially flexible members 232 (FIG. 3B), are selectivelytransitioned between the unexpanded and expanded states.

With reference to FIG. 3A, a tubular body block 270 having proximalgroove 271 may be formed on proximal end 210 a of tubular body 210.Tubular body block 270 may be formed of metal, rigid plastic, or othersubstantially rigid material and may be formed integrally with orattached securely to tubular body 210. Proximal groove 271 and theproximal end of tubular body block 270 may have a shape adapted tocooperate with a pair of tabs 279 a, 279 b formed on a locator assemblyblock 280, whereby tubular body block 270 may be maintained in a fixedaxial relationship with the locator assembly block 280. In this way,tubular body block 270 and tubular body 210 (FIG. 1B) may advancedistally by distal advancement of locator assembly block 280.

A locator assembly spring 290 may be located coaxially with and maysubstantially surround a portion of tubular body block 270. Locatorassembly spring 290 may be located between and in contact with thedistal side of two of tabs 279 a, 279 b formed on locator assembly block280 and the proximal side of locator assembly spring stop 381 formed onthe inner surface of housing bottom half 380 d. The locator assemblyspring 290 so located may provide a force biasing to locator assemblyblock 280 in the proximal direction relative to housing 380.

Locator assembly block 280 may be formed of metal, plastic, or otherrigid material. A function of locator assembly block 280 may be to allowa user to apply a force causing distal movement of tubular body 210(FIG. 1) relative to control member 250 causing locator assembly 200(FIG. 2) to transition from the unexpanded state to the expanded state.Slot 281 may be formed in the proximal end of locator assembly block280. Slot 281 may have a size sufficient to accommodate control block260 and control block cavity 265, and to allow locator assembly block280 to travel axially relative to housing 380. As shown in FIG. 1, thedistal end of locator assembly block 280 may include a pair of distallyextending legs 282 a-b, with each of legs 282 a-b having a ramp 283 a-bon its inward facing surface. Finally, the locator assembly block 280may have a pair of distally extending release tabs 284 a-b, each ofrelease tabs 284 a-b having a detent 285 a-b.

As shown in FIGS. 2-3A, locator assembly block 280 may be slidablyreceived and retained within grooves formed in the proximal end ofhousing 380, with the proximal end of locator assembly block 280extending from the proximal end of housing 380. Control block 260 andcontrol block cavity 265 may be located in slot 281 formed in theproximal end of locator assembly block 280.

To release locator assembly 200, and enable it to slidably move withinthe grooves formed in the proximal end of the housing 380 and allowlocator assembly 200 to transition from its expanded state to itsunexpanded state, the apparatus 100 can include a locator release system490 (FIG. 1A). Turning to FIG. 1A, locator release system 490 of theapparatus 100 may include locator release rod 491 having release tabspacer block 492 formed on its proximal end. Locator release rod 491 andrelease tab spacer block 492 may be received and retained in a grooveformed on the interior surface of housing bottom half 380 d. Release tabspacer block 492 may be integrally formed with or attached to theproximal end of locator release rod 491 and may be formed of metal,plastic, or other rigid material. Release tab spacer block 492 may havea shape and size adapted to fit between release tabs 284 a-b formed onlocator assembly block 280, thereby biasing release tabs 284 a-b outwardand causing outward facing detents 285 a-b to engage retaining grooves286 a-b (FIG. 1B) formed on the interior of housing 380. As long asdetents 285 a-b are thus engaged with retaining grooves 286 a-b inhousing 380, locator assembly block 280 is held in an axial positionagainst the spring force imparted in the proximal direction by locatorassembly spring 290.

With continued reference to FIG. 1A, the distal end of locator releaserod 491 may have an engagement member 493 that comprises an inward bendon the distal end of locator release rod 491. As described more fullybelow, engagement member 493 on locator release rod 491 may bepositioned within the apparatus 100 such that when closure element 500is delivered, engagement member 493 is engaged and caused to moveaxially in the distal direction, thereby disengaging release tab spacerblock 492 from locator assembly block 280 and causing locator assembly200 simultaneously to transition from an expanded state to an unexpandedstate.

Returning to FIG. 1A, the carrier assembly 120 may be coupled with, andslidable relative to, locator assembly 200. Carrier assembly 120 may beconfigured to receive and retain closure element 500, which may bedisposed substantially within carrier assembly 120. Carrier assembly 120may be further configured to position closure element 500 substantiallyadjacent to an opening to be closed, and to deploy closure element 500.Upon being deployed, closure element 500 can maintain a reducedcross-section but may also temporarily and substantially uniformlyexpand beyond the natural cross-section of closure element 500. Ineither case, closure element 500, when deployed, can engage an amount ofthe blood vessel wall and/or tissue adjacent to the opening. Thereafter,closure element 500 may be configured to return to the naturalcross-section, optionally substantially uniformly, such that the bloodvessel wall and/or tissue are drawn substantially closed and/or sealed.

As shown in FIG. 1A, carrier assembly 120 may include a tube set 305 ofat least one tubular member. For instance, the illustrated tube set caninclude carrier member 310, pusher member 320, cover member 330, andsupport member 340, also shown in FIG. 8. Carrier member 310, pushermember 320, cover member 330, and support member 340 may be provided asa plurality of nested, telescoping members with a common longitudinalaxis. Carrier member 310 may be configured to receive and supportclosure element 500. While being disposed on carrier member 310, closureelement 500 may be deformed from the natural, planar configuration toform a substantially tubular closure element 500″, as shown in FIGS.14A-14G, and as described herein.

Returning to FIG. 1A, carrier member 310 may include proximal end region310 a and distal end region 310 b. Carrier member 310 may also definelumen 314, which may extend substantially between proximal end region310 a and distal end region 310 b and configured to slidably receive atleast a portion of tubular body 210 of locator assembly 200 and/orsupport member 340. Although the exterior cross-section of the carriermember 310 may be substantially uniform, the distal end region 310 b ofcarrier member 310 may have a cross-section that increases distally, asillustrated in FIG. 1A, for substantially uniformly expandingsubstantially tubular closure element 500 (FIG. 14G) beyond naturalcross-section 530 (FIG. 14A) of closure element 500″ when substantiallytubular closure element 500″ is deployed. Alternatively, distal endregion 310 b may be formed with a uniform cross-section to deployclosure element 500 without cross-sectional expansion.

Pusher member 320 may have proximal end region 320 a and distal endregion 320 b. Pusher member 320 may be coupled with, and slidablerelative to, carrier member 310. Pusher member 320 may include apredetermined length and a predetermined cross-section, both of whichcan be of any suitable dimension and can be configured to slidablyreceive carrier member 310 such that distal end region 320 b of pushermember 320 may be offset proximally from distal end region 310 b ofcarrier member 310. As desired, the predetermined length of pushermember 320 may be substantially equal to a predetermined length ofcarrier member 310. A predetermined length of pusher member 320 may beless than a predetermined length of carrier member 310 such that carriermember 310 and pusher member 320 may at least partially define a space360 (FIG. 8) distal to distal end region 320 b of pusher member 320 andalong the periphery of carrier member 310.

Pusher member 320 may be substantially tubular and can define a lumen324 that may extend substantially between proximal end region 320 a anddistal end region 320 b and configured to slidably receive at least aportion of the carrier member 310. The cross-section of pusher member320 may be substantially uniform and distal end region 320 b of pushermember 320 can comprise one or more longitudinal extensions 325, whichmay extend distally from pusher member 320 and along the periphery ofcarrier member 310. Longitudinal extensions 325 may be biased such thatlongitudinal extensions 325 extend generally in parallel with the commonlongitudinal axis of carrier assembly 120. Longitudinal extensions 325may be sufficiently flexible to expand radially, and yet sufficientlyrigid to inhibit buckling as distal end region 320 b is directeddistally along carrier member 310 and engages the distally-increasingcross-section of distal end region 310 b of carrier member 310 to deployclosure element 500

Cover member 330 may be configured to retain closure element 500, in itsgenerally tubular configuration, substantially within the carrierassembly 120 prior to deployment. Being coupled with, and slidablerelative to, pusher member 320, cover member 330 has proximal end region330 a and distal end region 330 b, a predetermined length and apredetermined cross-section, both of which can be of any suitabledimension. Cover member 330 may be formed as a substantially rigid,semi-rigid, or flexible tubular member with an inner periphery and anouter periphery, and may define a lumen 334. Lumen 334 may extendssubstantially between proximal and distal end regions 330 a, 330 b ofcover member 330 and may be configured to slidably receive at least aportion of pusher member 320. When cover member 330 is properlypositioned within carrier assembly 120, as schematically illustrated inFIG. 15A, distal end region 330 b may be configured to extend over thespace 360, thereby defining annular cavity 370 for receiving andretaining substantially tubular closure element 500″.

The cross-section of cover member 330 may be substantially uniform, anddistal end region 330 b of cover member 330 may comprise one or morelongitudinal extensions 335, which extend distally from cover member 330and along an outer periphery of pusher member 320, as shown in FIG. 8.Although longitudinal extensions 335 can extend generally in parallelwith the longitudinal axis of the tube set 305, longitudinal extensions335 may be biased such that the plurality of longitudinal extensions 335extend substantially radially inward. Thereby, longitudinal extensions335 may at least partially close lumen 334 substantially adjacent todistal end region 330 b of cover member 330.

With reference to FIGS. 1B and 15A, to permit closure element 500 to bedeployed from annular cavity 370, longitudinal extensions 335 may besufficiently flexible to expand radially to permit distal end region 310b of carrier member 310 to move distally past cover member 330 to openannular cavity 370 such that distal end region 330 b no longer extendsover the space 360.

When carrier assembly 120 is assembled as a plurality of nested,telescoping members, as shown in FIGS. 2 and 8, carrier member 310 is atleast partially disposed within, and slidable relative to, a lumen ofpusher member 320, and support member 340 is slidably relative to pushermember 310. Pusher member 320, in turn, is at least partially disposedwithin, and slidable relative to, lumen 334 of cover member 330. Tocouple carrier assembly 120 with locator assembly 200, tubular body 210of locator assembly 200 may be at least partially disposed within, andslidable relative to, lumen 314. The longitudinal axis of locatorassembly 200 may be substantially in axial alignment with the commonlongitudinal axis of carrier member 310, pusher member 320, and covermember 330.

The apparatus 100 may also include support member 340 as shown in FIG.1A. Support member 340 may be configured to slidably receive tubularbody 210 of locator assembly 200 and provide radial support for distalend region 210 b of tubular body 210 when locator assembly 200 iscoupled with the carrier assembly 120. Carrier assembly 120 canadvantageously include support member 340, for example, if tubular body210 is not sufficiently rigid or under other circumstances in whichsupport for tubular body 210 might be desirable. It also will beappreciated that support member 340 may also be configured to inhibitlongitudinal extensions 335, which extend from distal end region 330 bof cover member 330, from expanding prematurely when closure element 500is deployed. If longitudinal extensions 335 were to expand prematurely,they may become hung up on an introducer sheath or other delivery member(if an introducer sheath or delivery member is used), the tissue, or thewall of the blood vessel. This may interfere with the proper advancementor other movement of cover member 330 and carrier assembly 120.

Support member 340 may be formed as a substantially rigid, semi-rigid,or flexible tubular member, and may include proximal end region 340 aand distal end region 340 b. Having an outer periphery, support member340 may define lumen 344, extending substantially between proximal endregion 340 a and distal end region 340 b and configured to slidablyreceive and support at least a portion of tubular body 210 of locatorassembly 200. Support member 340, in turn, can be at least partiallyslidably disposed within lumen 314 of carrier member 310 such thattubular body 210 of locator assembly 200 is coupled with, and slidablerelative to, carrier member 310 in the manner described in more detailabove.

Support member 340 may have a predetermined length and a predeterminedcross-section, both of which can be of any suitable dimension, and mayhave a substantially uniform cross-section. Although shown and describedas being substantially separate for purposes of illustration, it will beappreciated that carrier member 310, pusher member 320, cover member330, and/or support member 340 may be provided, in whole or in part, asone or more integrated assemblies.

With reference to FIG. 8, support member 340 may also include a distalend that is blunt, rounded and/or includes a radius or curved portionthat may prevent and/or eliminate damage to tubular body 200 as tubularbody is moved with respect to support member 340. In some cases duringdeployment, as discussed in more detail below, tubular body 200 may beinserted into a lumen of an introducer at such an angle as to requiretubular body 200 to flex with respect to tube set 305 as much as betweenabout 0 degrees and 90 degrees, preferably between about 10 degrees and90 degrees and more preferably between 30 degrees and 60 degrees, forexample when used in conjunction with a femoral artery. Theabove-described distal end of the distal end region 340 b preventsand/or eliminates damage to tubular body 200 that may result from asharp edge pressed along tubular body 200 during advancement of tube set305, and more particularly, support member 340 and the distal end of thedistal end region 340 b.

Illustratively, the radii of the distal end of the support member 340can have various sizes and configurations. In one configuration, thedistal end radii can be about 0.002 inches. In still anotherconfiguration, the distal end radii can be about 0.004 inches. In stillanother configuration, the distal end radii can be about 0.002 inches orgreater. Increasing the radii of the distal end of support member 340 toabout 0.004 inches, for instance, can decrease the amount of forcerequired to overcome a bend in locator assembly 200 over those deviceshaving a distal end radii of about 0.002 inches. This is because a gapformed between the interior diameter of support member 340 and thelocator assembly 200 is larger for the 0.004 inch radii than for the0.002 inch radii.

In addition to the above, with the distal end having a radii greaterthan 0.002 inches, such as but not limited to 0.004 inches, there is adecrease in the possibility that the support member 340 cuts orotherwise damages the locator assembly 200 during positioning of thedistal end of the apparatus 100 and subsequent deployment of the closureelement 500. Further, a radii greater than 0.002 inches, such as but notlimited to 0.004 inches, may not increase the forces used to split anintroducer sheath and may not elongate the introducer sheath duringpositioning and deploying of the closure element 500.

With reference to FIGS. 1A and 1B, carrier assembly 120 may also includea portion of housing 380. For instance, the carrier assembly 120 canoptionally include the top half 380 c of housing 380, illustrated inFIG. 1A, and the bottom half 380 d is shown in FIG. 1B. It will beunderstood, however, that housing 380 may be separate from the carrierassembly 120, while retaining and/or receiving all or a portion of thecarrier assembly 120.

Housing 380 may be formed as an elongate member with a longitudinalaxis, a periphery and may include proximal end region 380 a and distalend region 380 b. Thereby, when apparatus 100 is assembled, tubular body210 of locator assembly 200 may be at least partially disposed within,and slidable relative to, tube set 305 such that distal end region 210 bof tubular body 210 extends beyond distal end regions 310 b, 320 b, 330b, and/or 340 b. Tubular body 210, carrier member 310, pusher member320, cover member 330, and, if provided, support member 340 may be atleast partially disposed within, and slidable relative to, housing 380.Proximal end region 210 a of tubular body 210 and proximal end regions310 a, 320 a, 330 a, and/or 340 a of tube set 305 can be at leastpartially disposed within, and slidable relative to, housing 380. Distalend regions 210 b, 310 b, 320 b, 330 b, and 340 b may extend from distalend region 380 b of housing 380 such that common longitudinal axis 350of tube set 305 may be substantially axially aligned with longitudinalaxis 386 of housing 380. When configured to slidably retain respectiveproximal end regions 210 a, 310 a, 320 a, 330 a, and 340 a, housing 380supports tube set 305 and can have one or more handles 391, 392 tofacilitate use of apparatus 100. Handles 391, 392 may extend, optionallysubstantially radially, from the outer periphery of housing 380 and canbe provided as illustrated or in any manner known in the art.

To facilitate deployment of the closure element 500, the apparatus 100can include a triggering system 400, shown in FIG. 2, which cooperateswith a portion the locator assembly 200. For instance, a portion oflocator assembly 200 and a portion of triggering system 400 maycooperate and be accessible externally to housing 380, as shown in FIGS.1A and 1B. As shown in FIGS. 1A, 1B, 4-7, triggering system 400 ofapparatus 100 may be disposed substantially within housing 380.Triggering system 400 may be configured to control the relative axialmovement and/or positioning of distal end regions 310 b, 320 b, 330 b,and 340 b and/or locator assembly distal end region 210 b. Axial motionof one or more of carrier member 310, pusher member 320, cover member330, and support member 340 and/or tubular body 210 may be attained, forexample, by applying an axial force to triggering extension 405.

Triggering system 400 may include a set of block members includingcarrier block 410, pusher block 420, cover block 430, and support block440, each of which may be formed integrally with or securely attached toits respective member of carrier assembly 120. The block members may beadapted to selectably couple and decouple carrier member 310, pushermember 320, cover member 330, and support member 340 relative to oneanother in order to provide axial movement of those components in apredetermined manner intended to deliver closure element 500 in themanner described herein. For example, when carrier assembly 120 reachesa first predetermined distal position, support member 340 may bedecoupled from carrier member 310, pusher member 320, and cover member330, and may be thereafter substantially inhibited from further axialmovement. Thereby, carrier member 310, pusher member 320, and covermember 330 may be directed distally as support member 340 remainssubstantially stationary. Subsequently, carrier member 310 and covermember 330 can be decoupled from pusher member 320 and thereby inhibitedfrom further axial movement. Pusher member 320 may be directed distallyas support member 340, carrier member 310, and cover member 330 remainsubstantially stationary, as described more fully herein.

Carrier block 410 may be disposed on proximal end region 310 a ofcarrier member 310 and may include trigger extension 405, which extendsthrough a slot in housing 380 to the exterior of housing 380, accessibleby a user. This carrier block 410, as shown in FIG. 3A, may include apair of grooves 413 a-b formed on a peripheral surface of carrier block410. Grooves 413 a-b may be adapted to receive and retain a pair of tabs445 a-b formed on a pair of legs 444 a-b extending distally from supportblock 440, thereby selectably coupling support block 440 to carrierblock 410. Carrier block 410, as illustrated in FIG. 1A, may alsoinclude a pair of distal tabs 416 a-b extending from the distal end ofcarrier block 410, and adapted to engage a pair of slots 423 a-b formedon the proximal end of pusher block 420.

As shown in FIGS. 1A and 3A, carrier block 410 may also include a pairof arms 414 a-b extending in the proximal direction from the proximalend of carrier block 410, each of arm 414 a-b having an outward directedtab 415 a-b at its proximal end. Tabs 415 a-b may be adapted toselectably engage a pair of slots 387 a-b (FIG. 1B) formed on theinterior surface of housing 380 near its proximal end and, when soengaged, to fix the axial position of carrier block 410 and, with it,carrier assembly 120 relative to housing 380. Tabs 415 a-b may bedisengaged from slots 387 a-b FIG. 1B) in housing 380 when locatorassembly block 280 is moved axially in the distal direction in thefollowing manner. As locator assembly block 280 is advanced distally,the interior surfaces of the ramps 283 a-b on locator assembly blocklegs 282 a-b engage the exterior surfaces of tabs 415 a-b and causecarrier block arms 414 a-b to flex inward, releasing tabs 415 a-b fromthe slots 387 a-b in the housing, thereby freeing carrier block 410 andcarrier assembly 120 to move axially. Thus, axial movement of carrierblock 410 within apparatus 100 is inhibited until locator assembly block280 is advanced to transition locator assembly 200 to the expandedcondition, simultaneously releasing tabs 415 a-b on carrier block 410.

Pusher block 420 may be disposed on proximal end region 320 a of pushermember 320. As described above, pusher block 420 may include a pair ofslots 423 a-b formed on its proximal end, and adapted to selectablyengage distal tabs 416 a-b extending from the distal end of carrierblock 410. Pusher block 420 may also include a pair of grooves 424 a-bformed on its peripheral surface, the grooves 424 a-b being adapted toengage a pair of tabs 435 a-b formed on a pair of forks 434 a-bextending from the proximal side of cover block 430 to selectably couplecover block 430 to pusher block 420.

Cover block 430 may be disposed on proximal end region 330 a of covermember 330. As described above, cover block 430 may include a pair offorks 434 a-b extending from the proximal end of the cover block 430,each of forks 434 a-b having an inward directed tab 435 a-b adapted toengage grooves 424 a-b on the peripheral surface of pusher block 420 toselectably couple cover block 430 to pusher block 420.

Support block 440 may be disposed on proximal end region 340 a ofsupport member 340. As described above, support block 440 may include apair of legs 444 a-b extending from the distal end of the support block440, each of legs 444 a-b having an inward directed tab 445 a-b adaptedto engage grooves 413 a-b formed on the surface of carrier block 410 toselectably couple support block 440 to carrier block 410.

Carrier block 410, pusher block 420, cover block 430, and support block440 are shown in FIGS. 2, 3A, 4-5 in their fully coupled state, withsupport block 440 coupled to carrier block 410, pusher block 420 coupledto carrier block 410, and cover block 430 coupled to pusher block 420.In this arrangement, carrier assembly 120 comprises a coaxial set oftubes as shown in FIG. 8, with support member 340 slidably retainedsubstantially within carrier member 310, which is in turn slidablyretained substantially within pusher member 320, which is in turnslidably retained substantially within cover member 330.

Triggering system 400 of apparatus 100 may include an energy storingelement that is used in the final stage of closure element 500 deliveryprocesses. The energy storing element, such as, but not limited to, aspring, such as pusher spring 425 shown in FIGS. 1A, 1B, 6 and 7, may besubstantially retained in a spring cavity 417 formed in carrier block410 and coaxially surrounds a proximal end region 310 a of carriermember 310. Pusher spring 425 is capable of expanding and contracting,storing potential energy as it is contracted and releasing energy as itexpands. In its fully expanded state, the pusher spring 425 has a lengththat is greater than the length of spring cavity 417. Thecross-sectional dimension of pusher spring 425 may be such that it backsup against and contacts the proximal end of pusher block 420.

Thus, when pusher spring 425 is in place between carrier block 410 andpusher block 420, pusher spring 425 is capable of imparting a forcebiasing carrier block 410 away from pusher block 420.

Prior to delivery of closure element 500, the distal end of carrierblock 410 is in physical contact with the proximal end of pusher block420. In this pre-delivery condition, pusher spring 425 is in acontracted state and is maintained fully within spring cavity 417. Acatch member 418 serves the function of maintaining the carrier block410 and pusher block 420 in the pre-delivery condition against thespring force of pusher spring 425, the force of which would otherwiseforce apart carrier block 410 from pusher block 420. Catch member 418may be a U-shaped piece of metal, plastic, or other rigid material thatengages first groove 419 a formed on the surface of carrier block 410and second groove 419 b formed on the surface of pusher block 420. Withreference to FIGS. 1A and 1B, pusher block 420 includes hole 426extending through a portion thereof, with one end of hole 426 openinginto groove 419 b. Hole 426 is adapted to receive trip pin 427. Duringthe closure element deployment process, trip pin 427 is advanced throughhole 426, where it encounters catch member 418 retained in the groove419 b. Further advancement of trip pin 427 causes catch member 418 tobecome disengaged from groove 419 b, thereby releasing the force ofpusher spring 425.

The operation of the triggering system 400 of the apparatus 100 isillustrated in FIGS. 2-8 with the closure element 500 disposedsubstantially within the apparatus 100. As shown in FIGS. 2-3B,apparatus 100 has an initial position in which locator assembly block280 is extended proximally and triggering system 400 is in its mostproximal position. Accordingly, the locator assembly 200 is in itsunexpanded state, as shown in FIG. 3B. At a point in time that thedistal end region 210 b of the locator assembly 200 has been positionedas desired (for example, within the blood vessel), locator assemblyblock 280 is depressed distally, as shown in FIG. 4, therebytransitioning locator assembly 200 to the expanded state, as shown inFIG. 3C, and, simultaneously, releasing triggering system 400 from theinitial position (in the manner described above) such that triggeringsystem 400 can be advanced distally within the housing 380.

Triggering system 400 can then be advanced distally within housing 380,thereby advancing tube set 305 into position adjacent the blood vessel.At a first predetermined position, shown in FIGS. 4 and 5, support block440 encounters a support stop (not shown) on the interior surface ofhousing bottom half 380 d that inhibits support block 440 from advancingfurther distally. As a result, an application of additional distal forceto triggering system 400 causes support block 440 to decouple fromcarrier block 410. More specifically, tabs 445 a-b on legs 444 a-b ofsupport block 440 disengage from grooves 413 a-b on carrier block 410.Thus, support block 440 remains in the position shown in FIGS. 4 and 5,while carrier block 410 is able to advance further distally uponapplication of force to triggering system 400.

Turning to FIGS. 6-8, as the triggering system 400 is advanced furtherdistally; cover block 430 engages a cover stop on the interior surfacenear the distal end region 380 b of housing 380, thereby inhibitingadditional distal advancement of cover block 430. In addition, triggerextension 405 engages handle 391 of the apparatus, thereby inhibitingadditional distal advancement of carrier block 410.

Closure element 500 is next deployed by releasing pusher spring 425,which causes pusher block 420 (and, thus, pusher member 320 (FIG. 1A))to advance distally, deploying closure element 500 in the mannerdescribed above. As previously described, pusher spring 425 is releasedby disengaging catch member 418 from groove 419 b on pusher block 420,thereby releasing pusher spring 425 to force pusher block 420 and, thus,pusher member 320 distally relative to carrier block 410. This actioncauses pusher member 320 to deploy closure element 500 from withintubeset 305. The catch member 418 is disengaged from groove 419 b byapplying a force to a trigger 401, which, in the deployment position, isaligned with trip pin 427 retained in pusher block 420. A trigger spring402 biases trigger 401 outward relative to housing 380, with a portionof the trigger 401 extending through a hole 130 (FIG. 1B) in housing380. A user applies an inward directed force to trigger 401 tocounteract the biasing force of trigger spring 402 and force trigger 401against the trip pin 427.

With reference to FIGS. 1A and 6, in addition to deploying closureelement 500, the distal advancement of pusher block 420 also causeslocator release system 490 to activate, thereby transitioning locatorassembly 200 from the expanded state to the unexpanded state. As pusherblock 420 advances distally to deploy closure element 500 in the mannerdescribed above, pusher block 420 also engages engagement member 493 oflocator release system 490 and advances locator release rod 491distally. This action causes release tab spacer block 492 to disengagefrom release tabs 284 a-b on locator assembly block 280 (see FIG. 1),thereby releasing locator assembly block 280, which returns to itsproximal position, causing locator assembly 200 to return to theunexpanded state. An indicator window (not shown) may be formed inhousing 380 to give a visual indication that tab spacer block 492 hasdisengaged and that locator assembly 200 has returned to the unexpandedstate. The deployment of closure element 500 and locator release actionsoccur nearly simultaneously.

Referring now to FIGS. 9-13, an alternative embodiment of the apparatusis shown in accordance with the present invention. The apparatus of thealternative embodiment is functionally similar to that of the devicepreviously described above and shown in FIGS. 1-8 in most respects,wherein certain features will not be described in relation to thealternative embodiment wherein those components function in the manneras described above and are hereby incorporated into the alternativeembodiment described below.

Generally, the apparatus 1000 illustrated in FIGS. 9-13 can accommodatefor variations in the size of the physicians hand and grip byselectively reducing the distance between the device's handle portionand a portion of the triggering system usable to deploy the closureelement and/or move a carrier assembly. Advancement of a locatorassembly for locating the blood vessel wall prior to deploying theclosure element can at least partially advance a portion of thetriggering system of the apparatus including a trigger extensiongraspable by a physician or clinician. This partial movement reduces thegap or throw between the trigger extension and the handle portion. Inthis manner, a physician or clinician does not need to stretchuncomfortably to position a thumb or finger on the trigger extension,grasping the handle portion, and maintaining the device in the desiredorientation relative to the tissue and/or the puncture site.

As shown in FIG. 9, the apparatus 1000 can include a housing 1380comprising housing halves 1380 c and 1380 d (FIG. 10). These housinghalves 1380 c and 1380 d (FIG. 10), either individually or collectively,can form one or more handle, hand grip, or finger portions which aphysician or clinician can grip or hold to manipulate the apparatus1000. As illustrated, the apparatus 1000 can include finger grip 1391and finger grip 1392 at a distal end and finger grips 1394 a and 1394 bon the proximal end of housing 1380 to facilitate use of locatorassembly 1110, and specifically plunger 1280.

In addition, the apparatus 1000 can include handle, hand grip, or fingerportion disposed on the distal end of housing 1380 configured to beengaged by a user when advancing housing 1380 to deploy closure element500 (FIG. 1A). This handle or handle portion or hand grip portion caninclude a shaped grasping portion 1600 and an elongate grasping portion1392 spaced apart from the shaped grasping portion 1600. Each of theportions 1392 and 1600 may be contoured to be received by a user's hand.For instance, the grasping portion 1600 can provide a stable base uponwhich the physician or clinician can move the device or apparatus as theclosure element is positioned and deployed. This grasping portion 1600can have a shaped portion 1602 having a curved configuration that canreceive at least a thumb or finger of the physician as the physician orclinician holds the apparatus 1000. The curved configuration or profileallows the physician to grasp the handle or handle grip portion whileresting their hand, wrist or forearm upon a patient during theprocedure, such as deployment of the closure element, thereby providingstability during use of the device.

It will be understood that although reference is made to one particularconfiguration of the handle, hand grip, or finger portions, one skilledin the art will appreciate and can identify various other configurationsof handle portion that can perform the function of providing a stablebase for manipulation of the apparatus 1000. For instance, and not byway of limitation, the handle portion can be planar rather than curved.Further, the handle portion can include one or more finger receivingholes. In addition, the handle portion can include a material to providecushioning or comfort to the physician and/or clinician. For example,flexible, yielding, or elastic materials can be formed or applied to allor a portion of the handle portion.

Referring now to FIGS. 9 and 10, apparatus 1000 can be provided as oneor more integrated components and/or discrete components. For instance,and not by way of limitation, apparatus 1000 may include locatorassembly 1110 and carrier assembly 1120. For purposes of illustration,locator assembly 1110 and carrier assembly 1120 are shown in FIG. 10 ascomprising substantially separate assemblies. As desired, however,locator assembly 1110 and carrier assembly 1120 may each be provided, inwhole or in part, as one or more integrated assemblies. Portions oflocator assembly 110 and/or carrier assembly 120 can also be used aspart of apparatus 1000. Alternatively, modified versions of locatorassembly 110 and/or carrier assembly 120 can be used.

Locator assembly 1110 may be constructed in the manner previouslydescribed above, including a flexible or semi-rigid tubular body (suchas an elongate rail) with a longitudinal axis. The tubular body can havea proximal end region and a distal end region and can include apredetermined length and a predetermined outer cross-section, both ofwhich can be of any suitable dimension. The distal end region of thelocator assembly may include a substantially rounded, soft, and/orflexible distal end or tip to facilitate atraumatic advancement and/orretraction of the distal end region into a blood vessel or other openingin tissue. As desired, a pigtail (not shown) may be provided on thedistal end to further aid atraumatic advancement of the distal endregion. The distal end region of locator assembly 1110 may be selectablycontrollable between an unexpanded state and an expanded state.

As shown in FIG. 10, apparatus 1000 can include carrier assembly 1120which is functionally equivalent to carrier assembly 120 (FIG. 1A)described above and will not be described in detail with regard to thealternative embodiment. As with carrier assembly 120, carrier assembly1120 may be coupled with, and slidable relative to, locator assembly1110. Carrier assembly 1120 may be configured to receive and retain theclosure element 500 (shown in FIGS. 14A-14G), which can be disposedsubstantially within carrier assembly 1120. Carrier assembly 1120 canfunction to position closure element 500 substantially adjacent to anopening to be closed, and to deploy closure element 500.

Referring now to FIGS. 10 and 11, locator assembly 1110 of thealternative embodiment will be described in greater detail. As with theprevious locator assembly, a control member 1250, such as a rod, wire,or other elongate member, can be moveably disposed within a lumen (notshown) formed by tubular body 1210 and extend substantially between theproximal end region and the distal end region. Control member 1250 canhave a proximal end region 1250 a that may be coupled with a controlblock 1260, and a distal end region that may be coupled with the distalend region of locator assembly 1110, expansion members 1230, and/ormovable end regions of substantially flexible members, such as flexiblemembers 232 (FIG. 3B). Control block 1260 may be constructed in atubular shape and formed of a metal or rigid plastic, and is adapted tobe retained in control block cavity 1265 (FIG. 11A) formed on theinternal surface of the housing bottom half 1380 d, to thereby maintaincontrol block 1260 in a substantially fixed position relative to housinghalf 1380 d and so housing 1380. The locator assembly 1110 canselectively transition distal end region 1210 b, expansion members 1230,and/or the substantially flexible members between the unexpanded andexpanded states by moving tubular body 1210 axially relative to controlmember 1250. Additionally as shown in FIG. 11A, apertures 1383 may beplaced adjacent to an in communication with detents 1385, wherein in useas described below, tabs 415 a and 415 b (FIG. 1A) engage the detents1385 during use. Apertures 1383 are configured to receive the tip of amedical device, such as a tip of a dilator from a sheath assembly,wherein the tip of the dilator can be utilized to disengage the tabs 415a and 415 b (FIG. 1A) from the detents 1385 thereby releasing the lockedposition of the device. This enables a user to move the trigger assembly1400 (FIG. 10) proximally (toward the user) after the clip has beendeployed in the event that the device becomes stuck within the patient,thereby providing a safety release mechanism. It shall be appreciatedthat the apertures 1383 may be replaced by other features such arecessed buttons that become exposed with the engagement of the tabswith the detents or alternatively a specific tool may be provided withthe device.

With reference to FIGS. 10 and 11B, to facilitate movement of carrierassembly 1120 to reduce the distance between a trigger extension 1405and the distal end of housing 1380, the functionality of locatorassembly block 280 (FIG. 1A) can be provided through the combination ofa plunger 1280, a tubular body block 1270, and a spring retainer 1290.In addition to providing the functionality of locator assembly block280, including but not limited to, controlling movement of expansionmembers 1230, plunger 1280, tubular body block 1270, and spring retainer1290 aid with moving trigger extension 1405 toward the distal end ofhousing 1380.

With reference to FIG. 11B, plunger 1280 can include two spaced apartlegs 1282 a-b separated by a plunger member 1284 to form a slot 1281therebetween. The legs 1282 a-b are spaced apart sufficiently toaccommodate or receive a portion of tubular body block 1270 and/orspring retainer 1290 therebetween. Each of the legs 1282 a-b can have astepped configuration, such as shown in FIG. 11D. Plunger 1280 may beslidably received and retained within grooves formed in the proximal endof housing 1380, with the proximal end of plunger 1280 extending fromthe proximal end of housing 1380.

Plunger 1280 may be constructed of metal, plastic, or other rigidmaterial. The proximal end of plunger 1280 may have a slot 1281 formedtherein. Slot 1281 may have a size sufficient to accommodate controlblock 1260 and control block cavity 1265, and to allow plunger 1280 totravel axially relative to housing 1380. As mentioned, the distal end ofplunger 1280 has a pair of distally extending legs 1282 a-b withoptional ramps 1283 a-b on respective inward facing surfaces. Inaddition, formed in each leg 1282 a-b is a recess 1285 within whichmoves a protrusion 1286 having a dent 1288 that can interlock with atleast one of tubular body block 1270 or spring retainer 1290 as plunger1280 is moved distally.

With reference to FIGS. 11B and 11E, tubular body block 1270 may beformed integrally with or attached securely to tubular body 1210. Thetubular body block 1270 can include a pair of extending legs 1272 a-b,with each of legs 1272 a-b having a ramp portion 1273 a-b on its inwardfacing surface. Ramp portions 1273 a-b can cooperatively engage tabs,not shown but similar to tabs 415 a-b (FIG. 1A), of carrier block 1410(FIG. 12). In an initial state, the tabs 415 a-b (FIG. 1A) can beengaged in slots 1387 a-1387 b (FIG. 11A) formed in housing halve 1380 dto hold triggering system 1400 (FIG. 10) in a fixed axial relationshipwith housing 1380.

Extending between legs 1272 a-b is an intermediate member 1274 that caninclude a pair of upwardly extending extension 1276 a-b and a tab 1278,shown in dotted lines in FIG. 11B. Extensions 1276 a-b are receivedwithin the space between legs 1282 a-b of plunger 1280. Stated anotherway, tubular body block 1270 can be held in a fixed axial relationshipwith respect to plunger 1280 through the engagement of legs 1282 a-b andlegs 1272 a-b. The tab 1278 can be adapted to cooperate with springretainer 1290 and optionally lock with a portion of spring retainer 1290as plunger 1280 moves distally, as will be described in more detailhereinafter.

Extending from intermediate member 1274 in the same direction as legs1272 a-b is a tubular portion 1279 that slidably cooperates with springretainer 1290 and receives tubular body 1210 within a lumen. Further,tubular portion 1279 can cooperate with a locator assembly spring 1289(FIG. 10) which biases tubular body block 1270 and/or spring retainer1290 relative to housing 1380.

As shown in FIGS. 11B and 11F, spring retainer 1290 has a wall portion1291 with a recess 1292 that can receive tubular portion 1279 of tubularbody block 1270. The wall portion 1291 defines a channel 1294 withinwhich can be received locator assembly spring 1289 (FIG. 10). Forinstance, locator assembly spring 1289 (FIG. 10) can extend from wallportion 1291 to locator assembly spring stop 1381 (FIG. 11A) to biasmovement of spring retainer 1290, tubular body block 1270, and solocator assembly 1110.

Spring retainer 1290 can further include arms 1296 a-b. Arms 1296 a-bcan include a movable portion 1297 a-b that can flex or move to receivetab 1278 of tubular body block 1270. For instance, tab 1278 can includecurved surfaces that cooperate and receive a portion of movable portion1297 a-b as tubular body block 1270 moves relative to spring retainer1290. Alternatively, tab 1278 can be positioned within a space 1299between wall portion 1291 and movable portion 1297 a-b beforemanipulation or operation of apparatus 1000. It will be understood thatother portions of arms 1296 a-b can flex or move, whether or not movableportions 1297 a-b move.

In addition to arms 1296 a-b, spring retainer 1290 can include releasetabs 1298 a-b. These release tabs 1298 a-b can function in a similarmanner to tabs 284 a-b (FIG. 1A). For instance, tabs 1298 a-b cancooperate with a locator release system 1490 in a manner substantiallysimilar to the embodiments described above. For example, release tabs1298 a-b can engage release cavity 1495 on housing 1380, and can be heldfrom releasing by release tab spacer block 1492.

Generally, plunger 1280, tubular body block 1270, and spring retainer1290 can be formed of metal, plastic, or other material, whether or notrigid, substantially rigid, or flexible. As such, plunger 1280, tubularbody block 1270, and spring retainer 1290 can be formed from medicalgrade synthetic materials or materials that can be sterilized orotherwise cleaned.

Turning now to FIGS. 12 and 13, illustrated are the operationalpositions of the apparatus 1000 in (i) an initial state with theexpansion members 1230 (FIG. 9) in an unexpanded condition and (ii) astate with the expansion members 1230 (FIG. 9) in an expanded condition.

With reference to FIG. 12, in the initial state plunger 1280 extendsfrom the distal end of housing 1380, expansion members 1230 are in anunexpanded condition, and locator assembly spring 1289, which can belocated coaxially with tubular body block 1270, may be located betweenspring retainer 1290 and the proximal side of locator assembly springstop 1381 formed on the inner surface of housing bottom half 1380 d. Inthis initial state locator assembly spring 1289 is held in a biasedstate. Optionally, a portion of carrier assembly 1120 (FIG. 10) can beassociated with legs 1282 a-b of plunger 1280 and contact carrier aportion of carrier assembly 1120 (FIG. 10).

Once a user presses on plunger 1280 to expand expansion members 1230,that is moving plunger 1280 toward expansion members 1230, tubular bodyblock 1270 and tubular body 1210 are advanced distally by distaladvancement of plunger 1280. Upon advancement, and with reference toFIGS. 1A and 10-12, ramp members 1273 a-b press tabs 415 a-b, which arehidden by plunger 1280 in FIG. 12, releasing carrier block 1410 to slideaxially in housing 1380, and release tabs 1298 a-b engage in retaininggrooves 1387 a-b in cooperation with locator release system 1490, whichis functionally equivalent to locator release system 490 describedabove, thereby fixing spring retainer 1290 and tubular body block 1270axially with respect to housing 1380, and fixing expansion members 1230of locator assembly 1110 in an expanded state. Also during advancement,tab 1278 of tubular body block 1270 advances between arms 1296 a-b ofspring retainer 1290, extending the arms outwardly until tab 1278advances past the ends of arms 1296 a-b, causing arms 1296 a-b to extendbehind tab 1278, thereby coupling spring retainer 1290 and tubular bodyblock 1270, and fixing tubular body block axially prior to activation oflocator release system 1490. Also, once advanced the plunger 1280 islocked into a distal position by legs 1272 a and 1272 b.

Further axial movement of plunger 1280 can allow engagement of distalend 1283 b of leg 1282 b and carrier block 1410, thereby moving carrierblock 1410 distally along with carrier assembly 1120, as illustrated inFIG. 13. This additional movement of carrier assembly 1120 also movestrigger extension 1405, shortening the distance required to fully engagethe carrier assembly 1120. Combining the deployment of locator assembly1110 and the partial advancement of carrier assembly 1120 in a singlestep, allows for a reduction in travel of the trigger block and triggerextension 1405. This reduction of travel allows for a greater variationin user strength as well as the physical size of a users hand to fitbetter with device 1000 as illustrated.

Once locator assembly 1110 is deployed, carrier assembly 1120 can beadvanced distally by exerting force on trigger extension 1405, and canbe fixed in the distal position in the manner described above withreference to other embodiments above. After the locator has beendeployed and the carrier assembly initially advanced as shown in FIG.13, device 1000 functions in the manner described above with regard toother embodiments of the present invention and thus will not bedescribed in detail with regard to this embodiment.

In some embodiments, the tubular body block and the release block may beintegrally formed. When the tubular body block and the release block areintegrally formed, axial movement of the locator assembly block canforce outward movement of tabs holding the tubular body block to thelocator assembly block, allowing the integrally formed tubular bodyblock and release block to slide distally with respect to the locatorassembly block, and cause the release tabs to load the locator releasesystem to release as discussed above.

Referring now to FIGS. 14A-14G illustrating embodiments of a closureelement that can be used as part of or with the apparatus 100. Theclosure element, generally identified with reference numeral 500, mayhave a generally annular-shaped body defining a channel and one or morebarbs and/or tines for receiving and engaging the blood vessel walland/or the tissue around the opening. Although the closure element has anatural shape and size, the closure element can be deformed into othershapes and sizes, as desired, and can be configured to return to thenatural shape and size when released. For example, closure element 500can have a natural, planar configuration with opposing tines and anatural cross-section. The closure element can be formed from anysuitable material, including any biodegradable material, any shapememory material, such as alloys of nickel-titanium, or any combinationthereof. Additionally, it is contemplated that the closure element maybe coated with a beneficial agent or be constructed as a composite,wherein one component of the composite would be a beneficial agent. Asdesired, the closure element may further include radiopaque markers (notshown) or may be wholly or partially formed from a radiopaque materialto facilitate observation of the closure element using fluoroscopy orother imaging systems. Exemplary embodiments of a closure element aredisclosed in U.S. Pat. Nos. 6,197,042, 6,623,510, 6,461,364, 6,391,048,and 6,623,510. The disclosures of these references and any others citedtherein are expressly incorporated herein by reference.

As described previously, and with reference to FIG. 15A, closure element500 can be disposed within the carrier assembly and adjacent to thedistal end of pusher tube 320. As shown in FIG. 15A, for example, thereduced closure element 500 may be slidably received overdistally-increasing cross-section 318 b of distal end region 310 b ofcarrier member 310 and disposed about periphery 312 of carrier member310 adjacent to space 360. Since reduced cross-section 530 of reducedclosure element 500 is less than cross-section 318 b ofdistally-increasing cross-section 318 b, reduced closure element 500must be temporarily radially deformed to be received over distal endregion 310 b. Also, as reduced closure element 500′ (FIG. 14C) isreceived over distal end region 310 b, opposing tines 520 of reducedclosure element 500′ (FIG. 14C) engage distal end region 310 b. Reducedclosure element 500′ (FIG. 14C) thereby forms substantially tubularclosure element 500″, illustrated in FIG. 14G, with the ends of thebarbs and/or tines extending towards the distal end of the apparatus100.

The apparatuses of the present invention may be configured to beutilized with a sheath, wherein the sheath is inserted or otherwisepositioned into an opening in a body comprising a lumen. The sheathgenerally comprises a substantially flexible or semi-rigid tubularmember having a proximal end region and a distal end region and includesa predetermined length and a predetermined cross-section, both of whichcan be of any suitable dimension. The sheath forms a lumen that extendsalong a longitudinal axis or the sheath and substantially between theproximal and distal end regions. The lumen can have any suitableinternal cross-section and is suitable for receiving one or more devices(not shown), such as a catheter, a guide wire, or the like. The lumen isconfigured to slidably receive the tubular body of the locator assemblyand/or the tube set of the carrier assembly of the devices in accordancewith the present invention.

Since the internal cross-section of the sheath may be less than orsubstantially equal to the predetermined cross-section of the covermember, the sheath may be configured to radially expand, such as bystretching, to receive the tube set. Alternatively, or in addition, thesheath may be advantageously configured to split as the tube set isreceived by, and advances within the lumen of the sheath, therebypermitting the apparatuses to access the blood vessel wall. Tofacilitate the splitting, the sheath can include one or more splits,such as longitudinal splits, each split being provided in a manner knownin the art. Each split is configured to split the sheath in accordancewith a predetermined pattern, such as in a spiral pattern. It will beappreciated that, when the internal cross-section of the sheath isgreater than the predetermined cross-section of the cover member, it maynot be necessary for the sheath to be configured to radially expandand/or split. In addition to, or as an alternative to, the apparatus mayinclude a cutting means that initiates a tear line or split in thesheath when the sheath is engaged with the distal end of the apparatus.

The sheath may be advanced over a guide wire or other rail (not shown),which has been positioned through the opening and into the blood vesselusing conventional procedures such as those described above. Preferably,the blood vessel is a peripheral blood vessel, such as a femoral orcarotid artery, although other body lumens may be accessed using thesheath as will be appreciated by those skilled in the art. The opening,and consequently the sheath, may be oriented with respect to the bloodvessel such as to facilitate the introduction of devices through thelumen of the sheath and into the blood vessel with minimal risk ofdamage to the blood vessel. One or more devices (not shown), such as acatheter, a guide wire, or the like, may be inserted through the sheathand advanced to a preselected location within the patients body. Forexample, the devices may be used to perform a therapeutic or diagnosticprocedure, such as angioplasty, atherectomy, stent implantation, and thelike, within the patents vasculature.

FIGS. 15A-K illustrate one exemplary manner to deploy closure element500 by apparatuses according to the present invention. For purposes ofcontinuity, reference numbers to the first discussed embodiment areused, but it will be evident that other embodiments discussed above maybe used in a similar fashion.

A sheath 640 may be inserted or otherwise positioned through a patient'sskin 650 and tissue 630 and within the blood vessel 600 or other bodylumen via the opening 610. This provides access to the blood vessel 600through the blood vessel wall 620 for performance of a therapeutic ordiagnostic procedure.

After the procedure is completed, the devices associated with thetherapeutic or diagnostic procedure are removed from sheath 640, andapparatus 100 can be prepared to be received by lumen 644 of the sheath.Being in the unexpanded state, the distal end region 210 b of tubularbody 210 of the locator assembly 200 an be slidably received by thelumen and atraumatically advanced distally into the blood vessel 600, asillustrated in FIG. 15B. Once the distal end region 210 b extends intoblood vessel 600, distal end region 210 b can transition from theunexpanded state to the expanded state by activating the switchingsystem of locator assembly 200, and as illustrated in FIG. 15C. Asdiscussed with reference to the embodiments described in reference toFIGS. 9-13, the carrier assembly may be partially advanced when thelocator assembly is transitioned from the unexpanded to the expandedstate by pressing the locator assembly block distally with respect tothe housing.

Turning to FIG. 15D, apparatus 100 and/or sheath 640 can then beretracted proximally until distal end region 210 b is substantiallyadjacent to an outer surface 620 b of blood vessel wall 620. Distal endregion 210 b thereby draws blood vessel wall 620 taut and maintains theproper position of apparatus 100 as blood vessel 600 pulsates. Since theexpanded cross-section of distal end region 210 b is greater than orsubstantially equal to the cross-section of opening 610 and/or thecross-section of lumen 644, distal end region 210 b remains in bloodvessel 600 and engages inner surface 620 b of blood vessel wall 620.Distal end region 210 b can frictionally engage inner surface 620 b ofblood vessel wall 620, thereby securing apparatus 100 to blood vessel600. Sheath 640 can be retracted proximally such that distal end region640 b of sheath 640 is substantially withdrawn from blood vessel 600,permitting apparatus 100 to access blood vessel wall 620.

Once distal end region 210 b of locator assembly 200 contacts innersurface 620 b of blood vessel wall 620, tube set 305 can then beadvanced distally and received within lumen 644 of sheath 640. In themanner described above, sheath 640 can radially expand and/or split inaccordance with the predetermined pattern as tube set 305 advancesbecause the internal cross-section of sheath 640 is less than orsubstantially equal to pre-determined cross-section 338 b of covermember 330. Being coupled, carrier member 310, pusher member 320, covermember 330, and support member 340 each advance distally and approachthe first predetermined position, as illustrated in FIG. 15F. Asdiscussed with reference to the embodiments described in reference toFIGS. 9-13, a stable base can be provided by handle portion 1600 havingan enlarged, curved configuration that can receive at least a thumb orfinger of the physician. The enlarged, curved handle portion 1600 cangriped by the physician while the physician's hand is rested upon apatient during the procedure and provide stability during use of thedevice. Additionally, the combined deployment of locator assembly 1110and the partial advancement of carrier assembly 1120 in a single stepallows for a reduction in travel of trigger extension 1405. Thus, a userdoes not need to reach uncomfortably far from handle portion 1602 totrigger extension 1405 to fully advance carrier assembly 1120 and thetube set coupled to the carrier assembly.

Upon reaching the first predetermined position, tube set 305 is disposedsubstantially adjacent to outer surface 620 a of blood vessel wall 620adjacent to opening 610 such that the blood vessel wall adjacent toopening 610 is disposed substantially between expanded distal region 210b of locator assembly 200 and tube set 305. Support member 340 decouplesfrom carrier member 310 and pusher member 320 in the manner describedabove when tube set 305 is in the first predetermined position. Thecover member 330 and pusher member 320 are advanced. After advancementthe cover member 330 is decoupled from the carrier member 310 and pushermember 320. Thereby, cover member 330 and support member 340 may beinhibited from further axial movement and remain substantiallystationary as carrier member 310 and pusher member 320 each remaincoupled and axially slidable.

As shown in FIG. 15G, cover member 330 and support member 340 remainsubstantially stationary while carrier member 310 and pusher member 320continue distally and approach the second predetermined position. Ascarrier member 310 and pusher member 320 distally advance toward thesecond predetermined position, annular cavity 370 moves distallyrelative to substantially-stationary cover member 330 such that distalend region 330 b of cover member 330 no longer encloses annular cavity370. Thereby, closure element 500 is not completely enclosed by annularcavity 370 formed by distal end regions 310 b, 320 b, and 330 b ofcarrier member 310, pusher member 320, and cover member 330.

Although not completely enclosed by annular cavity 370, substantiallytubular closure element 500 is advantageously retained on outerperiphery 312 b of carrier member 310 by distal end region 330 b ofcover member 330 as illustrated in FIG. 15G. For example, by retainingsubstantially tubular closure element 500 between distal end region 330b of cover member 330 and distal end region 310 b carrier member 310,apparatus 100 may be configured to provide better tissue penetration.The timing between the deployment of substantially tubular closureelement 500 by tube set 305 and the retraction and transition to theunexpanded state by locator assembly 200 likewise is facilitated becausesubstantially tubular closure element 500 is retained between distal endregion 330 b and distal end region 310 b. Further, carrier member 310and cover member 330 operate to maintain substantially tubular closureelement 500 in the tubular configuration.

When tube set 305 is in the second predetermined position, carriermember 310 decouples from pusher member 320 in the manner described indetail above. Therefore, carrier member 310, cover member 330, andsupport member 340 may be inhibited from further axial movement andremain substantially stationary, whereas, pusher member 320 remainsaxially slidable. As pusher member 320 continues distally, distal endregion 320 b of pusher member 320 contacts substantially tubular closureelement 500 and displaces substantially tubular closure element 500 fromspace 360 as shown in FIG. 15H. Since space 360 is substantiallyradially exposed, pusher member 320 directs substantially tubularclosure element 500 over the distally-increasing cross-section of distalend region 310 b of substantially-stationary carrier member 310 suchthat the cross-section of substantially tubular closure element 500begins to radially expand, preferably in a substantially uniform manner.As substantially tubular closure element 500 traverses thedistally-increasing cross-section of distal end region 310 b, thecross-section of substantially tubular closure element 500 radiallyexpands beyond natural cross-section of closure element 500, as shown inFIGS. 14A-G.

Upon being directed over the distally-increasing cross-section of thedistal end region by pusher member 320, substantially tubular closureelement 500 is distally deployed as illustrated in FIG. 15I. Whensubstantially tubular closure element 500 is deployed, tines 520 canpierce and otherwise engage significant amount of blood vessel wall 620and/or tissue 630 adjacent to opening 610. For example, tines 520 canengage significant amount of blood vessel wall 620 and/or tissue 630because cross-section 530 of substantially tubular closure element 500is expanded beyond natural cross-section 530 of closure element 500during deployment.

As the closure element is being deployed from the space, locatorassembly 200 may begins to retract proximally and locator release system490 can be activated to transition from the expanded state to theunexpanded state as substantially tubular closure element 500 isdeployed. Distal end region 210 b of locator assembly 200 may retractproximally and transition from the expanded state to the unexpandedstate substantially simultaneously with the deployment of substantiallytubular closure element 500. As desired, distal end region 210 b may beconfigured to draw blood vessel wall 620 and/or tissue 630 adjacent toopening 610 proximally and into the channel defined by substantiallytubular closure element 500. Tines 520 of substantially tubular closureelement 500 thereby can pierce and otherwise engage blood vessel wall620 and/or tissue 630.

Turning to FIG. 15J, substantially tubular closure element 500, oncedeployed, begins to transition from the tubular configuration, returningto the natural, planar configuration with opposing tines 520 and anatural cross-section of closure element 500. Preferably, substantiallytubular closure element 500 substantially uniformly transitions from thetubular configuration to the natural, planar configuration. Rotatingaxially inwardly to from opposing tines 520 of the closure element 500,tines 520 draw the tissue into the channel as substantially tubularclosure 500 element forms closure element 500. Also, the tissue is drawnsubstantially closed and/or sealed as the cross-section of substantiallytubular closure element 500 contracts to return to the naturalcross-section.

It will be appreciated that the closure element may be constructed ofother materials, that it may comprise alternative shapes, and that itmay adopt alternative methods of operation such that the closure elementachieves closure of openings in blood vessel walls or other body tissue.In an additional non-limiting example, the closure element isconstructed of materials that use a magnetic force to couple a pair ofsecuring elements in order to close an opening in the lumen wall ortissue. In this alternative embodiment, the closure element may be of aunitary or multi-component construction having a first securing elementpositionable at a first position adjacent the opening, and a secondsecuring element positionable at a second position adjacent the opening.The first and second securing elements are provided having a magneticforce biasing the first and second securing elements together, therebyclosing the opening, or they are provided having a magnetic forcebiasing both the first and second securing elements toward a thirdsecuring clement positioned in a manner to cause closure of the opening.The magnetic closure element may be provided without tines, provided themagnetic force coupling the closure elements is sufficient to close theopening. Alternatively, the closure element may be provided with acombination of the magnetic securing elements and tines to provide acombination of coupling forces. Those skilled in the art will recognizethat other and further materials, methods, and combinations may beutilized to construct the closure element to achieve the objectivesdescribed and implied herein.

The invention is susceptible to various modifications and alternativemeans, and specific examples thereof have been shown by way of examplein the drawings and are herein described in detail. It should beunderstood, however, that the invention is not to be limited to theparticular devices or methods disclosed, but to the contrary, theinvention is to cover all modifications, equivalents, and alternativesfalling within the spirit and scope of the claims.

We claim:
 1. A method for delivering a closure element to an openingformed in a wall of a body lumen, the method comprising: inserting adistal end region of an apparatus into the opening in the wall of thebody lumen, the apparatus comprising a first grasping portion, a secondgrasping portion, and a third grasping portion, wherein the secondgrasping portion and third grasping portion are movable toward the firstgrasping portion; moving the third grasping portion toward the firstgrasping portion to limit movement of the distal end of the apparatusrelative to the opening in the wall of the body lumen; and moving thesecond grasping portion toward the first grasping portion to advance theclosure element distally.
 2. The method as recited in claim 1, whereinmoving the third grasping portion deploys a locator across the opening.3. The method as recited in claim 1, wherein moving the third graspingportion positions a member transverse to the opening.
 4. The method asrecited in claim 1, wherein moving the third grasping portion furthercomprises advancing a portion of the third grasping portion into aportion of a housing of the apparatus.
 5. The method as recited in claim1, further comprising releasing a locking member to allow a slidableproximal member to move distally toward the distal end of the apparatus.6. The method of claim 5, wherein releasing the locking member comprisesmoving the locking member from a locked state to an unlocked state. 7.The method of claim 1, wherein moving the second grasping portiondisconnects the closure element from the apparatus.
 8. A method fordelivering a closure element to an opening formed in a wall of a bodylumen, the method comprising: positioning a distal end region of anapparatus r the opening in the wall of the body lumen, the apparatuscomprising a first grasping portion, a second grasping portion, and athird grasping portion, wherein the second grasping portion and thirdgrasping portion are axially movable toward the first grasping portion;moving the third grasping portion axially toward the first graspingportion to limit movement of the distal end of the apparatus relative tothe opening in the wall of the body lumen; and moving the secondgrasping portion axially toward the first grasping portion to advancethe closure element distally in preparation to disconnect the closureelement from the apparatus.
 9. The method of claim 8, wherein one of thefirst grasping portion, the second grasping portion and the thirdgrasping portion includes a through-hole.
 10. The method of claim 8,wherein one of the first grasping portion, the second grasping portionand the third grasping portion is formed in a housing.
 11. The method asrecited in claim 8, wherein moving the third grasping portion positionsa member transverse to the opening.
 12. The method as recited in claim11, wherein moving the third grasping portion moves a portion of thethird grasping portion disposed outside of the apparatus into a portionof the apparatus.
 13. The method of claim 8, wherein moving the secondgrasping portion disconnects the closure element from the apparatus. 14.The method of claim 8, further comprising removing the distal end of theapparatus from the opening.
 15. The method of claim 8, wherein the firstgrasping portion and the second grasping portion have complementaryorientations.
 16. A method for delivering a closure element to anopening formed in a wall of a body lumen, the method comprising:positioning a distal end region of an apparatus relative to the openingin the wall of the body lumen, the distal end being movable between anexpanded state and an unexpanded state, the apparatus comprising a firstgrasping portion, a second grasping portion, a third grasping portion,and a slidable proximal member, the movement of which relative to thehousing being limited by a locking member having a locked state and anunlocked state, wherein the second grasping portion and third graspingportion are axially movable toward the first grasping portion; movingthe third grasping portion axially toward the first grasping portion tomove the distal end of the apparatus to an expanded state; moving thelocking apparatus from the locked state to an unlocked state; moving theslidable proximal member distally to support the distal end regionrelative to the opening in the wall of the body lumen; and moving thesecond grasping portion axially toward the first grasping portion toadvance the closure element distally and deploy the closure element fromthe apparatus.
 17. The method as recited in claim 16, wherein moving thethird grasping portion to move the distal end of the apparatus to theexpanded state comprises positioning a portion of the distal endtransverse to the opening.
 18. The method as recited in claim 16,wherein moving the second grasping portion deploys the closure elementinto engagement with the tissue surrounding the opening.
 19. The methodas recited in claim 16, further comprising advancing a tubular memberover a guide wire and removing the guide wire from the tubular member.20. The method as received in claim 19, wherein positioning the distalend region of the apparatus relative to the opening in the wall of thebody lumen comprising moving the distal end region relative to thetubular member.